Compositions and Methods for Cognitive, Immune and Digestive Support in Patients with Autism Spectrum Disorder

ABSTRACT

The present invention provides compositions and methods for improving the quality of life for a subject, particularly a child, diagnosed with autism spectrum disorder (ASD). In preferred embodiments, a supplement composition comprising natural or naturally-derived ingredients is delivered to a subject in the form of a chocolate bar or other candy alongside administration of an antiviral medication. Advantageously, the composition and methods can improve the immune health of the subject, along with other signs and symptoms associated with ASD, infections and other immunocompromising conditions.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Patent Application, Ser. No. 62/551,557, filed Aug. 29, 2017, which is incorporated herein by reference in its entirety.

BACKGROUND OF INVENTION

Autism spectrum disorder (ASD) refers to a group of neurodevelopment disorders, including autistic disorder (autism), Asperger syndrome, childhood disintegrative disorder, and pervasive developmental disorders, which are characterized by repetitive, distinctive patterns of behavior and difficulties with social communication and interaction. Subjects with ASD may have a combination of many symptoms and syndromes, which are typically present from early childhood and affect daily functioning.

Included within ASD is a wide range of symptoms, skills, and levels of functional disability. Some children and adults with ASD are fully capable of performing all activities of daily life, while others require substantial support to perform basic life functions and activities. Additionally, individuals with ASD may experience pathologic changes such as brain inflammation, gastrointestinal problems, immune system imbalance, lipid metabolism imbalance, and possible increased risk of cancer due to links between autism and mutations in cancer-associated genes and pathways.

The prevalence of ASD in children in the United States has been increasing rapidly over the past 50 years. At present, the rate of ASD prevalence is 1 case for every 59 children born. Compared to 2016, when it was 1 in 68 children; 2008, when it was 1 in 125 children; and 50 years ago, when it was 1 in 2500 children, the present statistics indicate that ASD prevalence is not only increasing, but actually doubling every ten years.

Considerably more males are affected with ASD than females. For some individuals, the core symptoms of ASD (i.e., impairments in communication and social interaction, and restricted/repetitive behaviors and interests) may improve with intervention and maturation; however, core deficits typically translate into varying developmental presentations that endure throughout the lifespan.

The exact cause of ASD development is not entirely clear, and the underlying root of ASD symptoms, such as damaged brain structures and impaired nerve connections, cannot be readily corrected by existing medications. However, drugs useful in treating other diseases with similar symptoms can be useful in managing ASD, though none have been approved by the FDA for treating ASD specifically.

It is known that ASD does have a strong genetic component, with heritability estimated to be as high as 90% in some studies. Identification of specific genetic risk variants has proved to be challenging, however, and many researchers suggest that there may be multiple pathways to the disorder, with prenatal and postnatal insult potentially contributing to its development in some instances. For example, certain metabolic and other maternal conditions (e.g., diabetes, hypertension, obesity and infection), as well as consumption of alcohol and certain medications (e.g., antidepressants) during pregnancy may be associated with increased risk of ASD in offspring.

Additionally, maternal immune malfunction during pregnancy, including chronic immune activation of microglia, may also cause some alterations in a child's brain. The connection is explained by possible upregulation of brain inflammatory cytokines resulting from immune activation in the mother, which then leads to presence of these cytokines in sera and frontal and cingulate cortices of the fetal brain. This is thought to affect the course of brain development, which may lead to ASD.

Much of the research into ASD etiology points to congenital chronic infections as a cause for development of the disorder. Many of these infections are viral, including Herpes Simplex Virus (HSV) 1 and 2, Human Herpes Virus (HHV) 6, Epstein-Barr Virus, Rubella virus, Measles virus, Cytomegalovirus (CMV), BK virus, JK virus, SV40 virus, and others.

For example, it was reported in 2005 that in the USA, approximately 40,000 children are born with congenital cytomegalovirus (CMV) infection, and Binda et al. found that congenital CMV was found 10 times more often in blood of children with ASD than in healthy children. Human herpes virus-6 was found in children with ASD 3.5 times more often than within healthy children. Epstein-Barr virus (EBV) was found in patients with multiple sclerosis and ASD. Congenital rubella syndrome caused by transmission of rubella virus from mother to fetus also strongly affects the brain development, and children with ASD are infected 200 times more often than healthy children. Additionally, the combination of three viruses: BK virus, JC virus and simian virus 40 was found two times more often in children with ASD than in healthy controls.

Furthermore, the roles of herpes simplex viruses (HSV) 1 and 2 in influencing the development of a number of neurodevelopmental disorders, including schizophrenia, Alzheimer's disease, epilepsy, and ASD have also been studied.

The mechanism by which viral infection may lead to autism is not yet clear. One theory is that, once a subject is infected, many viruses have the ability to localize in certain brain sections, or through infection elsewhere in the body, trigger disease in the central nervous system. This might in turn disturb normal brain development. The mechanism may also occur through immune responses in the mother while a fetus is developing, which may lead to weakening of the fetus's immune system and further lead to disturbances in brain development.

There is no cure for ASD, but current therapies and behavioral interventions exist, which are designed to improve certain symptoms of the disorder; however, most existing treatments focus on treating the brain and cognitive functions specifically, rather than the other potential underlying causes of ASD and its symptoms. For example, repetitive transcranial magnetic stimulation (rTMS) is a type of brain stimulation therapy that has been tested as a treatment tool for various neurological and psychiatric disorders, including migraines, strokes, Parkinson's disease, dystonia, tinnitus, depression, and auditory hallucinations, where a coils is placed near the patient's head to depolarize or hyperpolarize neurons of the brain. In particular, rTMS uses electromagnetic induction to induce weak, repetitive electrical currents using a rapidly changing magnetic field to cause activity in desired brain regions. While this may produce short-term relief from certain cognitive and brain-related symptoms, it does not treat, for example, compromised immune health underlying a neurodegenerative condition.

The ideal treatment plan for a subject diagnosed with ASD coordinates therapies and interventions that meet the specific needs of the individual, based on where he or she falls on the spectrum. Most health care professionals agree that the earlier the intervention, the better.

Thus, there is a continuing need for new, integrated compositions and methods for treating a broad range of ASD symptoms and improving the overall quality of life and performance for patients—particularly children—diagnosed with autism and its spectra.

BRIEF SUMMARY

The present invention provides compositions and methods for improving cognitive, immune and/or digestive functioning in subjects with autism spectrum disorder (ASD) and other immunocompromising conditions. Advantageously, embodiments of the present invention provide compositions and methods for modulating the immune system and improving the quality of life for subjects, particularly children, with ASD.

In certain embodiments, the present invention provides a supplement composition for improving the quality of life for a subject diagnosed with ASD, wherein the composition comprises ingredients that help support immune health and suppress infectious agents in the subject's body. Additionally, a majority, if not all, of these ingredients can be natural or naturally-derived.

In one embodiment, the subject invention provides a supplement composition that comprises L-Iysine, Elderberry extract, olive leaf extract, Astragalus root extract, and Bacillus coagulans GBI-30 probiotic (BC30).

In a further embodiment the supplement composition comprises, consists of, or consists essentially of L-lysine, Elderberry extract, olive leaf extract, Astragalus root extract, and Bacillus coagulans BC30.

In preferred embodiments, the supplemental composition is used in conjunction with an antiviral agent such as, for example, valacyclovir

Thus, in one embodiment, the present invention provides a method for improving the quality of life for a subject diagnosed with ASD or another immunocompromising condition, wherein the method comprises administering to the subject therapeutically-effective amounts of an antiviral compound and a supplement composition of the present invention.

In one embodiment, the method can be used to treat symptoms of ASD, including behavioral, mental, emotional and/or physiological symptoms.

The antiviral compound can include prescription drugs and/or naturally-derived treatments. Preferably, the antiviral compound is a prescription drug selected from common drug compounds valacyclovir, acyclovir, famciclovir, ganciclovir, valganciclovir, ribavirin, brivudin, cidofovir, fomivirsen, foscarnet, penciclovir, vidarabine and others used to treat chronic, congenital, persistent, latent, dormant, acute and/or subacute viral infections.

In one embodiment, the method first comprises testing the subject for and/or diagnosing the subject with ASD and/or another immunocompromising condition, such as a viral infection. In one embodiment, the method can first comprise testing the subject for signs of poor immune health, for example, by testing the subject for immune marks such as T-cells and NK cells. In one embodiment, the testing is performed using known blood testing methods.

In one embodiment, the subject being treated according to the present invention has previously contracted an infection, currently has an infection, or has been exposed to one or more infectious agents. In preferred embodiments, the infection is due to a chronic virus.

In one embodiment, the subject is diagnosed specifically with autistic disorder or autism. In on embodiment, the subject is diagnosed with one or more of cytomegalovirus, Epstein-Barr virus, rubella virus, measles virus, herpes simplex type 1 or 2, herpes zoster, other herpes family viruses, or any other chronic, congenital, persistent, latent, dormant, acute and/or subacute viral infection.

The subject of the present invention can be any human diagnosed with an immunocompromising condition and/or with ASD. In one embodiment, the human subject is a child or adolescent, for example, 16 years of age or younger.

Advantageously, the present invention can improve the quality of life for immunocompromised subjects who are diagnosed with, for example, ASD and/or a viral infection. The present invention can lead to simultaneous improvement of mental, emotional and physiological symptoms of ASD, improvement in behavioral performance, and improvement in sign and symptoms of viral infections.

BRIEF DESCRIPTION OF THE FIGURE

FIG. 1 shows an example of a questionnaire given to parents of children diagnosed with ASD prior to undergoing a treatment according to the subject invention.

DETAILED DISCLOSURE

The present invention provides compositions and methods for treating subjects with an autism spectrum disorder (ASD) and/or an immunocompromising condition. Advantageously, the subject invention can improve the immune health and overall quality of life of a subject—particularly a child—diagnosed with ASD and/or an immunocompromising condition.

Selected Definitions

The terms “autism spectrum disorder” and “ASD” are used in this disclosure to refer to a spectrum of disorders characterized by abnormalities of social interactions and communication, as well as restricted interests and repetitive behavior. This spectrum includes, but is not limited to, autistic disorder (autism), Asperger's syndrome, childhood disintegrative disorder, atypical autism or pervasive developmental disorder not otherwise specified (PPD-NOS), as well as Rett syndrome and tuberous sclerosis.

As used herein, “treating” or “treatment” means the eradicating, improving, reducing, ameliorating or reversing of at least one sign or symptom of a condition or disorder. Treatment can include, but does not require, a complete cure of the condition or disorder, meaning treatment can also include partial eradication, improvement, reduction, amelioration or reversal. Treatment can also include delaying, forestalling and/or inhibiting the progression of a condition or disorder to a more severe condition or disorder.

Signs and/or symptoms encompass those of ASD or of any comorbidity of ASD. Signs and symptoms associated with ASD include, but are not limited to irritability; hyperactivity; inattention; abnormalities in speech, verbal, communication, and language skills; repetitive behavior, including stereotypy, compulsive behavior, sameness (resistance to change), and ritualistic behavior; obsessive focus on certain topics and/or objects; inability to make eye contact; abnormalities in social interactions and/or understanding of others' feelings; anger issues and/or emotional outbursts; self-injury; and others.

Comorbidities of ASD include but are not limited to anxiety; attention deficit disorder; brain inflammation; viral infections; clinical depression; Tourette syndrome; Fragile X syndrome; obsessive-compulsive disorder; bipolar disorder; learning disabilities; sensory disorders; developmental coordination disorder; disorders of the immune system and/or gastrointestinal system, including candidiasis; seizures and/or epilepsy; sleep disorders; increased risk of cancer; and others.

The terms “therapeutically effective” amount or dose, “effective amount,” and “effective dose” are used in this disclosure to refer to an amount of a compound or composition that, when administered to a subject, is capable of providing a desired therapeutic effect or a desired level or treatment. The actual amount of the compound or composition will vary depending on a number of factors including, but not limited to, the particular disorder being treated, the severity of the disorder, the size and health of the patient, and the route of administration. A skilled medical practitioner can readily determine the appropriate amount using methods known in the medical arts.

A plant “extract,” as used herein, refers to the material resulting from exposing a plant part to a solvent and removing the solvent, or from using various chemical, immunological, biochemical or physical procedures known to those of skill in the art, including but not limited to, precipitation, centrifugation, filtering, column chromatography, and detergent lysis. Plant material can include roots, stems, leaves, flowers, or parts thereof.

As used herein, the term “probiotic” refers to microorganisms, which, when administered in adequate amounts, confer a health benefit on the host. The probiotics may be available in foods and dietary supplements (for example through capsules, tablets, and powders). Non-limiting examples of foods containing probiotics include dairy products such as yogurt, fermented and unfermented milk, smoothies, butter, cream, hummus, kombucha, salad dressing, miso, tempeh, nutrition bars, and some juices and soy beverages. In preferred embodiments, the microorganisms are live.

The terms “natural” and “naturally-derived,” as used in the context of a chemical compound or substance is a material that is found in nature, meaning that it is produced from earth processes or by a living organism. A natural product can be isolated or purified from its natural source of origin and utilized in, or incorporated into, a variety of applications, including foods, beverages, cosmetics, and supplements. A natural product can also be produced in a lab by chemical synthesis, provided no artificial components or ingredients (i.e., synthetic ingredients that cannot be found naturally as a product of the earth or a living organism) are added.

The terms “isolated” or “purified,” when used in connection with biological or natural materials such as nucleic acid molecules, polynucleotides, polypeptides, proteins, organic compounds, such as small molecules, microorganism cells/strains, or host cells, means the material is substantially free of other compounds, such as cellular material, with which it is associated in nature. That is, the materials do not occur naturally without these other compounds and/or have different or distinctive characteristics compared with those found in the native material.

In certain embodiments, purified compounds are at least 60% by weight the compound of interest. Preferably, the preparation is at least 75%, more preferably at least 90%, and most preferably at least 99% or 100% (w/w) of the desired compound by weight. Purity is measured by any appropriate standard method, for example, by column chromatography, thin layer chromatography, or high-performance liquid chromatography (HPLC) analysis.

The description herein of any aspect or embodiment of the invention using terms such as “comprising,” “having,” “including,” or “containing” with reference to an element or elements is intended to provide support for a similar aspect or embodiment of the invention that “consists of,” “consists essentially of,” or “substantially comprises” that particular element or elements, unless otherwise stated or clearly contradicted by context (e.g., a composition described herein as comprising a particular element should be understood as also describing a composition consisting of that element, unless otherwise stated or clearly contradicted by context).

The term “consisting essentially of,” as used herein, limits the scope of the ingredients and steps to the specified materials or steps and those that do not materially affect the basic and novel characteristic(s) of the present invention.

Supplement Compositions

In certain embodiments, the present invention provides a supplement composition for improving the quality of life for a subject diagnosed with ASD or another immunocompromising condition, wherein the supplement composition comprises ingredients that help support immune health and suppress infectious agents in the subject's body. Additionally, a majority, if not all, of these ingredients can be natural or naturally-derived.

In one embodiment, the supplement composition comprises L-lysine, Elderberry extract, olive leaf extract, Astragalus root extract, and Bacillus coagulans GBI-30 probiotic (BC30).

In a further embodiment the supplement composition comprises, consists of, or consists essentially of L-lysine, Elderberry extract, olive leaf extract, Astragalus root extract, and Bacillus coagulans BC30.

In one embodiment, the supplement composition helps support the immune system of a subject with a compromised immune system, for example, a subject diagnosed with ASD and/or a viral infection. As used herein, the term “support” can include boosting, improving, enhancing, and/or maintaining the proper functioning of a body system, for example, those involved in the immune system.

Immune support can include support for the cells, tissues, and organs that contribute to proper functioning of the immune system, for example, the lymphatic system, spleen, bone marrow, or any other system involved in production of entities (e.g., antibodies, lymphocytes, red blood cells, white blood cells, platelets) that ward off foreign substances (e.g., inoculants such as bacteria, viruses, parasites, and fungi) from the body's normal and healthy tissues. Immune support can further include support for parts of the body that aid in preventing and healing from injury, inflammation, cancer, or other non-infectious diseases, ailments, or conditions.

In some aspects, the supplement composition can also help support other body systems that are known to be interrelated with immune health, such as the circulatory, endocrine, urinary, muscular, respiratory, skeletal, central nervous, digestive, integumentary, and reproductive systems.

In other words, the subject composition can be effective in supporting more than one body system, particularly where the health of one body system promotes the health of another.

In one embodiment, L-lysine is present in the supplement composition in amounts up to 750 mg, up to 500 mg, up to 250 mg or up to 125 mg.

L-lysine is an essential amino acid found naturally in, for example, meats, beans, cheeses, eggs and other casein-containing foods. It is important for proper growth, muscle protein building and metabolism, and can be effective in reducing anxiety, mood disturbances and headaches. Furthermore, L-lysine reduces the cyto-pathogenicity of HSV through reduction in the herpes virus load.

In one embodiment, Elderberry extract is present in the supplement composition in amounts up to 750 mg, up to 500 mg, up to 250 mg or up to 125 mg.

Elderberry extract comprises extract from the fruit and/or flowers of plants of the black elder plant (Sambucus nigra). It is a well-known immune-boosting substance containing anthocyanins, flavonoids, vitamins, minerals and antioxidants. Elderberry extract has been shown to alleviate allergies, protect against certain infections such as cold and flu viruses, reduce toothaches and headaches, moderate digestion, and exhibit activity against HSV 1. Furthermore, the flavonoids and anthocyanins in elderberry extract provide anti-inflammatory, anti-oxidant and immunostimulatory properties.

In one embodiment, olive leaf extract (Olea europaea) is present in the composition in amounts up to 750 mg, up to 500 mg, up to 250 mg or up to 125 mg.

Olive leaf extract is well known as a multi-functional alternative treatment for many diseases and conditions. The chemical compounds found in olive leaf extracts, including polyphenols, flavonoids, oleuropein, tyrosol, and hydroxytyrosol, and more particularly the active ingredient elenolic acid, have antibacterial, antioxidant, antiviral, neuroprotective and antifungal properties, thereby making olive leaf extract effective in fighting a wide range of diseases, including: influenza, EBV, CMV, common cold, bacterial/viral meningitis, postsurgical infections, kidney infections, shingles, hepatitis, pneumonia and malaria. Additionally, olive leaf can affect the down-regulation of genes that participate in inflammatory processes, thus making it a useful anti-inflammatory compound. Furthermore, olive leaf extract is through to be effective for regulation of lipid and carbohydrate metabolism as well as hypoglycemia.

In one embodiment, Astragalus root extract is present in the composition in amounts up to 750 mg, up to 500 mg, up to 250 mg or up to 125 mg.

Astragalus root extract can be obtained from the roots of an Astragalus plant species, including, for example, Astragalus membranaceus. This extract has antibacterial, antiviral, anti-inflammatory, antioxidant, anti-aging, and anti-cancer properties. Furthermore, Astragalus intake enhances production of immune system cells and stimulation of growth of stem cells.

In one embodiment, Bacillus coagulans GBI-30 probiotic (“BC30”) is present in the composition in amounts from 1×10⁸ to 1×10¹² CFU, preferably 1×10⁹ to 1×10¹¹ CFU, and more preferably 2 billion CFU.

BC30 has been shown to promote digestive health, aide in reducing inflammation, and regulate imbalances in lipid metabolism and the immune system. Moreover, BC30 intake can increase immune response to viral agents, such as influenza A virus and adenovirus and inhibit some herpes family viruses.

BC30 is a preferred probiotic for the present invention because it is capable of surviving the acidity of the stomach, thus allowing it to reach the intestines. BC30 contains a natural protective layer of proteins, which allows it to not only survive the harsh environment of the stomach, but also allows it to survive most manufacturing processes. Moreover, BC30 may also out-compete other harmful bacteria that cause infections or may have other deleterious effects. BC30 may delay the onset of symptoms and promote quicker recovery from infection and/or colitis caused by Clostridium dificile. BC30 may also be helpful in replenishing beneficial bacteria in the intestines for individuals who have been prescribed antibiotics.

Formulation and Delivery of Supplement Compositions

In a preferred embodiment, the supplement composition of the present invention is formulated so that it can be delivered to a subject orally. In particular, the composition is formulated as an orally-consumable product.

Orally-consumable products according to the invention are any preparations or compositions suitable for consumption, for nutrition, for oral hygiene or for pleasure, and are products intended to be introduced into the human or animal oral cavity, to remain there for a certain period of time and then to either be swallowed (e.g., food ready for consumption) or to be removed from the oral cavity again (e.g. chewing gums or products of oral hygiene or medical mouth washes). These products include all substances or products intended to be ingested by humans or animals in a processed, semi-processed or unprocessed state. This also includes substances that are added to orally-consumable products (e.g., active ingredients such as extracts, nutrients, supplements, or pharmaceutical products) during their production, treatment or processing and intended to be introduced into the human or animal oral cavity.

Orally-consumable products can also include substances intended to be swallowed by humans or animals and then digested in an unmodified, prepared or processed state. These include casings, coatings or other encapsulations that are intended also to be swallowed together with the product or for which swallowing is to be anticipated.

Preferably, the orally-consumable product according to the invention is formulated as a composition to be consumed for nutrition or pleasure. These particularly include baked goods (e.g., bread, dry biscuits, cake, cookies, brownies and other pastries), sweets and candies (e.g., chocolates, chocolate bar products, other bar products, gummies, fruit leathers, jelly beans, coated tablets, hard candies, toffees and caramels, and chewing gum), non-alcoholic beverages (e.g., cocoa, coffee, green tea, black tea, herbal teas, lemonades, isotonic beverages, soft drinks, nectars, fruit and vegetable juices, and fruit or vegetable juice preparations), instant beverages (e.g., instant cocoa beverages, instant tea beverages, instant smoothies, instant milkshakes and instant coffee beverages), meat products (e.g., cold cuts, fresh or raw sausage preparations, seasoned oder, marinated fresh meat or salted meat products), eggs or egg products (e.g., dried whole egg, egg whites, and egg yolks), cereal products (e.g., breakfast cereals, muesli bars, and pre-cooked instant rice products), dairy products (e.g., whole fat or fat reduced or fat-free milk beverages, rice pudding, yoghurt, kefir, cream cheese, soft cheese, hard cheese, dried milk powder, ice cream, sherbet, whey, butter, buttermilk, and partly or wholly hydrolyzed products containing milk proteins), products produced from nuts (e.g., nut milks, nut butters, nut flours or powders), products from soy protein or other soy bean fractions (e.g., soy milk and products prepared thereof, beverages containing isolated or enzymatically treated soy protein, soy flour containing beverages, preparations containing soy lecithin, fermented products such as tofu or tempeh products prepared thereof and mixtures with fruit preparations and, optionally, flavoring substances), fruit preparations (e.g., jams, fruit ice cream, fruit sorbets, fruit smoothies, fruit sauces, and fruit fillings), vegetable preparations (e.g., ketchup, sauces, dried vegetables, deep-freeze vegetables, pre-cooked vegetables, and boiled vegetables), snack articles (e.g., chips, crisps, pretzels, biscuits, crackers and nuts), products on the basis of fat and oil or emulsions thereof (e.g., mayonnaise, remoulade, and dressings), other ready-made meals and soups (e.g., dry soups, instant soups, and pre-cooked soups), seasonings (e.g., sprinkle-on seasonings), sweetener compositions (e.g., tablets, sachets, and other preparations for sweetening beverages or other food). The present compositions may also serve as semi-finished products for the production of other compositions intended for nutrition or pleasure.

Preferably, the present composition is delivered by an orally-consumable product that appeals to children, for example, in the form of a sweet treat or snack. In a preferred embodiment, the composition is delivered in the form of a chocolate bar, a gummy or a jelly.

When formulated as a chocolate bar, the chocolate can be dark chocolate, light chocolate, milk chocolate, white chocolate or a mixture thereof. Optionally, caramel, nut butters, fruit or fruit fillings, coconut, sprinkles, chips (chocolate or other), candies, or any of a variety of other flavorings or food products can be added to the bar to enhance the taste and appeal thereof.

Preferably, the chocolate bars are packaged in blister packs, or in larger, multi-dose break-apart bars with individual sections constituting one dose. The chocolate bars can also be packaged as individually wrapped single-dose bars.

In certain embodiments, the composition is formulated as a gummy or a jelly, or some other form of gelatinous or chewy candy. For example, the composition can be formulated as a gummy bear, gummy worm, or other well-known gummy candy, a fruit snack, a fruit tape, a fruit leather, a jelly bean or a taffy. A single dose of the supplement composition can be included in one piece of the candy, or divided between a pre-determined number of candies, for example from 2 to 5 pieces.

The composition of the subject invention can also be present in the form of capsules, tablets (uncoated and coated tablets, e.g., gastro-resistant coatings), coated tablets, granules, pellets, solid-substance mixtures, dispersions in liquid phases, as emulsions, powders, solutions, pastes or other swallowable or chewable preparations, or as a dietary supplement.

For oral administration, tablets or capsules can be prepared by conventional means with acceptable excipients such as binding agents, fillers, lubricants, disintegrants, or wetting agents. The tablets can be coated, if desired. Liquid preparations for oral administration can take the form of, for example, solutions, syrups, or suspension, or they can be presented as a dry product for constitution with saline or other suitable liquid vehicle before use.

The compositions described herein can also contain acceptable additives as will be understood by one skilled in the art, depending on the particular form of the delivery method. Non-limiting examples of such additives include suspending agents, emulsifying agents, non-aqueous vehicles, preservatives, buffer salts, flavoring, coloring, and sweetening agents as appropriate. Non-limiting examples of specific additives include: gelatin, glycerin, water, beeswax, lecithin, cocoa, caramel, titanium dioxide, and carmine. Preparations for oral administration also can be suitably formulated to give controlled release of the active ingredients.

In some cases, the composition provided herein can contain an acceptable carrier for administration to a human subject or other mammal including, without limitation, sterile aqueous or non-aqueous solutions, suspensions, and emulsions. Examples of non-aqueous solvents include, without limitation, propylene glycol, polyethylene glycol, vegetable oils, and organic esters. Aqueous carriers include, without limitation, water, alcohol, saline, and buffered solutions. Acceptable carriers also can include physiologically acceptable aqueous vehicles (e.g., physiological saline) or other known carriers appropriate to specific routes of administration.

Methods for Improving the Quality of Life in Immunocompromised Subjects

The present invention further provides a method for improving the quality of life for a subject diagnosed with ASD or another immunocompromising condition, wherein the method comprises administering to the subject a therapeutically-effective dose of an antiviral compound and a supplement composition of the present invention.

Advantageously, the present invention can improve the quality of life for immunocompromised subjects who are diagnosed with, for example, ASD and/or an infection. In other words, the present invention can lead to simultaneous improvement of, for example, the mental, emotional and physiological symptoms of ASD, improvement in behavioral performance, improvement in the signs and symptoms of infections, and improvement in the overall immune health of the subject.

In one embodiment, the method can be used to improve symptoms of ASD, including behavioral, mental, emotional and/or physiological symptoms.

The subject of the present invention can be any human diagnosed with ASD or exhibiting the signs and symptoms thereof. In one embodiment, the human subject is a child or adolescent, for example, 16 years of age or younger.

In one embodiment, the subject is a child diagnosed with ASD or who exhibits the signs and symptoms thereof. In another embodiment, the subject has a compromised immune system, for example, due to genetics, illness, or because the subject previously contracted or was exposed to a viral or bacterial infection. The subject may presently be exhibiting signs of infection, or the subject may be asymptomatic because, for example, contraction of the virus occurred at some time in the past, e.g., in utero.

In specific embodiments, the subject has contracted or been exposed to a viral infection thought to be associated with alteration of immune system functioning and/or development of ASD, including but not limited to the following long-term or chronic viruses: cytomegalovirus (CMV); Rubella virus; measles virus; varicella zoster virus (VZV); Epstein-Barr virus (EBV), herpes simplex virus types 1 and 2 (HSV); human herpes virus (HHV); BK virus (BKV); JC virus (JCV); and simian virus 40 (SV40).

Viral infection or exposure according to the subject disclosure typically occurs early on in a subject's development, either through vertical transmission (i.e., from mother to embryo, fetus, or infant during pregnancy or childbirth), direct transmission (i.e., contact from another infected subject), or indirect transmission (e.g., through a vector).

In some embodiments, the method comprises the step of diagnosing the subject with ASD prior to administering the antiviral to the subject. In further embodiments, the method comprises, the step of testing the subject for infection or signs of exposure to an infection prior to administering the antiviral to the subject. This can be done using, for example, blood tests that detect certain antibodies. In one embodiment, the method can also comprise performing an immune analysis on the subject to test for overall immune health and/or the presence of any immunocompromising conditions.

According to one embodiment, the step of administering antiviral treatment comprises administering a therapeutically-effective dose of a prescription antiviral medication. The antiviral compound according to the subject methods can include prescription drugs and/or naturally-derived treatments. Preferably, the antiviral compound is a prescription drug selected from the commonly used drug compounds valacyclovir, acyclovir, famciclovir, ganciclovir, valganciclovir, ribavirin, brivudin, cidofovir, fomivirsen, foscarnet, penciclovir, vidarabine and others used to treat chronic, congenital, persistent, latent, dormant, acute and/or subacute viral infections.

In a preferred embodiment, the antiviral medication is selected from the group consisting of valacyclovir (also known as Valtrex), acyclovir (also known as Zovirax), ganciclovir (also known as, e.g., Cytovene) and famciclovir (also known as Famvir).

Each of these commercially available drugs was originally designed for treatment of adults infected with herpes family viruses. Valacyclovir, most commonly administered for treating and suppressing genital herpes, can be given to patients with ASD to suppress the herpes virus, if present, and decrease inflammation and neurological dysfunction it causes. Valacyclovir can also be useful in managing and/or treating herpes zoster (shingles), cytomegalovirus, EBV, mononucleosis, and herpes B.

Valacyclovir is the prodrug of acyclovir, another common antiviral treatment. Acyclovir differs from valacyclovir in that it typically requires more frequent dosage.

Children with ASD may show improvements in any aspect of their spectrum of symptoms in response to treatment with these antiviral medications, including but not limited to improvement in behavioral performance.

In embodiments of the present invention, administration of the antiviral medication occurs daily for several months or longer. Administration can include any known method of drug administration, including, but not limited to, oral, nasal, cutaneous (e.g., applying it as a cream), or intravenous administration. In preferred embodiments, administration is performed orally once or twice daily.

The medication can be administered in cycles, for example, four months on with two months off, or three weeks on with one week off. Cycles can be repeated multiple times, for example three times, or as many times as deemed necessary by a skilled physician.

In a preferred embodiment, the antiviral treatment is valacyclovir. Valacyclovir can be administered to the subject once or twice a day, at up to 500 mg per dose, up to 250 mg per dose or up to 125 mg per dose. Proper dosage of the antiviral treatment is determined by a skilled physician based on the individual receiving treatment, with factors such as age and symptoms considered.

In preferred embodiments, at the start of treatment, the antiviral compound is administered to the subject on its own for one week, two weeks or three weeks, to determine whether the subject will experience any adverse side-effects from the medication. Then, the supplement composition can be introduced into the treatment while the antiviral treatment is continued.

In one embodiment, the supplement composition is ingested by the subject once, twice, or three times per day, determined on a subject-by-subject basis by a skilled physician. Factors to be considered when determining the number of doses to administer include the age of the individual receiving treatment and the severity of his/her symptoms.

The concomitant administration of antiviral and supplement composition can be continued for one or more consecutive cycles lasting, for example, 21 days or longer. A cycle can be repeated as many times as necessary without breaking in between, for example, 3 times or more. In one embodiment, the antiviral treatment can be discontinued after a certain number of cycles, and administration of the supplement composition can optionally be continued indefinitely.

In one embodiment, the method comprises administering a supplement composition comprising L-lysine, Elderberry extract, olive leaf extract, Astragalus root extract, and Bacillus coagulans GBI-30 probiotic (BC30).

In another embodiment, the method comprising administering a supplement composition comprising, consisting of, or consisting essentially of L-lysine, Elderberry extract, olive leaf extract, Astragalus root extract, and Bacillus coagulans GBI-30 probiotic (BC30).

More specifically, the method can comprise administering L-Lysine in amounts up to 750 mg, up to 500 mg, up to 250 mg or up to 125 mg; Elderberry extract in amounts up to 750 mg, up to 500 mg, up to 250 mg or up to 125 mg; olive leaf extract in amounts up to 750 mg, up to 500 mg, up to 250 mg or up to 125 mg; Astragalus root extract in amounts up to 750 mg, up to 500 mg, up to 250 mg or up to 125 mg; and Bacillus coagulans GBI-30 probiotic (BC30) in amounts up to 1×10¹² CFU, more preferably 2 billion CFU.

In one embodiment, the amount of each of L-Lysine, Elderberry extract, olive leaf extract, and Astragalus root extract is from about 125 mg to about 750 mg, from about 125 mg to about 500 mg, and/or from about 125 mg to about 250 mg. In one embodiment, the amount of BC30 is from about 1×10⁸ CFU to about 1×10¹², from about 1×10⁹ to about 1×10¹¹ CFU, or about 2 billion CFU.

In one embodiment, the subject undergoes periodic blood work throughout the treatment time period, for example every week, every month, or every two months. The blood testing can not only be used to monitor the level of, for example, viral antibodies and/or viral load in a subject, but also monitor how the subject's liver, kidneys, blood cells and other body functions are operating. These tests can serve as precautionary safeguards, as harmful side effects from these treatments are rare or even nonexistent.

In some embodiments, the methods disclosed herein can also include measuring a baseline of behavioral performance and/or overall health prior to treatment of the subject according to the subject methods, and/or measuring the behavioral performance and/or overall health after treatment. The methods can include comparing the behavioral performance and/or overall health prior to and after treatment is administered to the subject, and the comparison can be used to determine if and to what extent the behavioral performance and/or overall health in the subject is improved, or if adjustments should be made to the treatment given.

As used herein, the phrase “improvement in behavioral performance” refers to reduction in the severity or frequency, to whatever extent, of one or more of the behavioral disorders, symptoms and/or abnormalities expressed by an individual suffering from ASD, or a pathological condition having behavioral symptoms similar to those of ASD. The improvement is either observed by the individual taking the treatment themselves or by another person (medical professional or otherwise).

In the method disclosed herein, behavioral performance can be measured and evaluated using various parameters and methods. For example, behavioral tests can be conducted to determine the presence and/or extent of restricted repetitive behavior and/or stereotyped behavior patterns of the subject under test. In some embodiments, the Autism Behavior Checklist (ABC), Autism diagnostic Interview-Revised (ADI-R), childhood autism Rating Scale (CARS), and/or Pre-Linguistic Autism Diagnostic Observation Schedule (PL-ADOS) is used for the behavioral test. The behavioral test can include, but is not limited to, detecting the presence and/or extent of (1) preoccupation with one or more stereotyped and restricted patterns of interest that is abnormal in either intensity or focus; (2) inflexible adherence to specific, nonfunctional routines or rituals; (3) stereotyped and repetitive motor mannerisms (such as hand flapping, finger flapping etc.); and/or (4) persistent preoccupation with parts of objects. Non-limiting examples of behavior that can be included in a behavioral test and suggest a need for improving behavioral performance in the subject under the test include:

(a) Sensory behaviors: poor use of visual discrimination when learning; seems not to hear, so that a hearing loss is suspected; sometimes shows no “startle response” to loud noise; sometimes painful stimuli such as bruises, cuts, and injections evoke no reaction; often will not blink when bright light is directed toward eyes; covers ears at many sounds, squints, frowns, or covers eyes when in the presence of natural light; frequently has no visual reaction to a “new” person; stares into space for long periods of time;

(b) Relating behaviors: frequently does not attend to social/environmental stimuli; has no social smile; does not reach out when reached for; non-responsive to others' facial expressions/feelings; actively avoids eye contact; resists being touched or held; is flaccid when held in arms; is stiff and hard to hold; does not imitate other children at play; has not developed any friendships; is often frightened or very anxious; “looks through” people;

(c) Body and object use behaviors: whirls self for long periods of time; does not use toys appropriately; insists on keeping certain objects with him/her; rocks self for long periods of time; frequently lunges and darts; flaps hands; walks on toes; hurts self by banging head, biting hand, etc.; twirls, spins, and bangs objects frequently; will feel, smell, and/or taste objects in the environment; performs complicated “rituals” such as lining things up; is very destructive; and

(d) Language behaviors: does not follow simple commands given once; has pronoun reversal; speech is atonal; does not respond to own name when called out among others; seldom says “yes” or “I”; does not follow simple commands involving prepositions; uses gestures to get desired objects; repeats phrases over and over; cannot point to more than five named objects; uses 0-5 spontaneous words per day to communicate wants and needs; repeats sounds or words over and over; echoes questions or statements made by others; uses at least 15 but less than 30 spontaneous phrases daily to communicate; learns a simple task but “forgets” quickly; has strong reactions to changes in routine/environment; has “special abilities” in one area of development, which seems to rule out mental retardation; has severe temper tantrums and/or frequent minor tantrums; hurts others by biting, hitting, kicking, etc.; does not wait for needs to be met; has difficulties with toileting; does not dress self without frequent help; is frequently unaware of surroundings and may be oblivious to dangerous situations; prefers to manipulate and be occupied with inanimate things; and a developmental delay was identified at or before 30 months of age.

One of ordinary skill in the art would appreciate that the attending physician would know how to identify a subject in need of treatment disclosed herein.

EXAMPLES

The examples described below illustrate exemplary embodiments of the method of the subject invention. These exemplary embodiments should not be construed as limiting the scope of the subject invention.

Materials and Methods

Parents of children with confirmed ASD diagnoses were asked to have the following tests performed on their children prior to participating in the treatment study: (1) complete blood count; (2) cellular immunity state (T-lymphocytes mature CD3+CD19, mature T-lymphocytes CD3+CD19− abs, B-lymphocytes CD19+CD3−, B-lymphocytes CD19+, T-helper cells CD3+CD4+T-helper cells CD3+CD4+ abs, T-cytotoxic CD3+CD8+T-cytotoxic CD3+CD8+ abs, index T-helper cells/cytotoxic CD4+/CD8+T-lymphocytes act of CD3+HLA-DR+, T-cells act of CD3+HLA-DR+ abs, lymphocytes act of CD3−HLA-DR+, Lymphocytes act CD3−HLA-DR+ abs, NK-cell CD3−CD16+/CD56+, NK-cell CD3−CD16+/CD56+ abs, T-NK-cell CD3-CD16+/CD56+); and (3) antibody tests (Epstein-Barr virus NA IgG, Epstein-Barr virus VCA IgM, Cytomegalovirus IgG, Cytomegalovirus IgM, HSV 1,2 IgM, HSV 1,2 IgG, Rubella IgM, Rubella IgG, Mycoplasma hominis IgG, Mycoplasma hominis IgM, Mycoplasma pneumonia IgG, Mycoplasma pneumonia IgM, Helicobacter pylori IgG, Chlamydia pneumonia IgG, and Chlamydia pneumonia IgM).

The parents were then asked to fill in questionnaires (see FIG. 1 for an example of questions asked) reflecting the presence of the ASD symptoms and their severity. The questions related to, for example, behavioral patterns and difficulties, level of functioning, cognitive functioning, language ability, learning impairment, comorbidities, physiological and psychological condition (e.g., sleep disorders, epilepsy, gastrointestinal issues, malfunction of the immune system, anxiety, depression and/or hyperactivity). The severity of the symptoms was measured using the ADI-R scale. (0-symptom is absent, 3—a symptom is strongly pronounced).

The children were divided into three age groups: (1) 2-3 years old; (2) 3 to 7 years old; and (3) 7 years and older. The treatment started with intake of valacyclovir for two weeks. The supplement composition was added after the two week period, when the absence of side-effects due to antiviral treatment was confirmed.

For children of group (1), the valacyclovir dosage was 125 mg, twice a day. All supplements were prescribed at a dosage of 125 mg each, once a day, and probiotic BC-30 with dosage 2 billion CFUs. One treatment cycle was 21 days long.

For children of group (2), the treatment scheme was the same but with valacyclovir dosage increased to 250 mg, twice a day, and supplement dosage increased to 250 mg each, once a day. BC-30 dosage remained at 2 billion CFUs.

For children of group (3), the valacyclovir dosage was increased to 500 mg, twice a day, and supplement dosage increased to 500 mg each, once a day. Again, BC-30 dosage remained at 2 billion CFUs.

For all three groups the scheme consisted of 3 consecutive cycles, 21 days each, of daily valacyclovir treatment and supplement intake.

Behavioral and comorbidity changes were observed in subjects after treatment was underway for one month, as well as monitoring of blood for viral antibodies and other immune responses.

Specific behavioral changes and improvements sought to be observed were improvements in speech, language and verbal skills; reduction in repetitive movements or unusual behaviors; reduction of obsessive behavior; improvements in social interactions, including ability to make eye contact with others; increased interest in other children; improved understanding other people's feelings or talking about own feelings; improved anger management and reduction of emotional outbursts; and any others specific to a particular child.

In addition, changes and improvements related to comorbidities sought to be observed were reduced anxiety; improved attention deficit; reduced hyperactivity; changes in clinical depression; improved gastrointestinal symptomology; changes in intellectual abilities; changes in obsessive behavior; reduction is seizures and epileptic paroxysms; changes in sensory sensitivities; and changes in sleep disorders.

Example 1—6-Year-Old Male “K. A.”

Prior to treatment, the child's parents reported that the child displayed the followed signs and symptoms of ASD: verbal delays; unclear speech or spoke only learned phrases; did not answer questions; could not express requests from others; exhibited some stereotypical movements with hands; did not play with children and toys or know how to join children's games; anger outbursts when he did not get what he wanted; anxiety; hyperactivity; frequent constipation; excessive sensitivity; hiding under his blanket; and sleep problems.

The initial test for the presence of infections revealed EBV IgG, CMV IgG, rubella IgG, and Helocobacter pylori IgG. The immune analysis showed the decreased level of T-helpers, T-lymphocytes, and IRI, and increased level of T-suppressors and NK cells. Blood analysis identified the increased level of erythrocytes and distribution of erythrocytes by volume.

After 1 month of the subject antiviral and supplement therapy, the parents reported the following changes: 5-6 new words appeared in the vocabulary; he started performing requests; repeatability of movements and stims decreased; improvements in understanding other people, including his mother; decreased anxiety with a calmer demeanor; hyperactivity decreased slightly; and her stopped hiding under his blanket.

Blood tests revealed the following physiological changes: rubella IgG dropped by over 58% (from 106 to 62, ref. value 10), CMV antibodies decreased by 12.6% (from 10.15 to 8.87, ref. value 1); T-helpers value returned to a normal value (from 25.14% to 43.6%, ref. value 30-50%), as well as T-lymphocytes (from 59.78 to 63%, ref value 60-80%), IRI (from 0.6 to 1.2, ref value 1.2-2), and NK cells (from 25.81 to 16.7%, ref value 8-17%) (see Table 1).

TABLE 1 Changes in blood, immune and infectious status in “K.A”. Reference Before After 1 month Indices value treatment of treatment EBV IgG 1 9.9 10.2 CMV IgG 1 10.15 8.87 Rubella IgG 10 106 62 Helicobacter Pylori 1.24 1.2 0 IgG T-helpers 30-50% 25.14% 43.6% T-lymphocytes 60-80% 59.78% 63%   IRI 1.2-2      0.6 1.2 T-suppressors 18-25% 41.42% 37.8% NK cels  8-17% 25.81% 16.7% Erythrocytes 10{circumflex over ( )}12/L 3.8-4.9    5.3 5.3 Distribution of 11.5-14.5% 15.8%  16 erythrocytes by volume

Example 2—12-Year-Old Male “A. T.”

Prior to treatment, the child's parents reported that the child displayed the followed signs and symptoms of ASD: speech delays; repetition of certain words; unclear speech, only using separate words; poor understanding of speech; exhibited some stereotypical movements, including waiving of hands; difficulties making eye contact; could not play with children because they did not understand each other; and excessive focus on objects when he wanted them (repeating the name of the object until he got it and could not concentrate on anything else).

The initial test for the presence of infections revealed CMV IgG, HSV IgG, Mycoplasma IgG, EBV IgG, and Helicobacter Pylori IgG. Blood analysis identified the increased level of erythrocytes, hematocrit, amount of hemoglobin, and distribution of erythrocytes by volume.

After 1 month of the subject antiviral and supplement therapy, the parents reported the following changes: the child started to build sentences; he lost weight (from size L to M); new words appeared in his vocabulary and he started speaking more and more clearly; he started expressing verbally when he did not like something; and his writing skills improved.

Blood tests revealed the following physiological changes: antibodies to CMV became three times lower (from 68 to 21, ref value 1); and mycoplasmas and Helicobater pylori disappeared. The level of erythrocytes became lower and approached the normal level (from 5.7. to 5.27, ref value 3.60-5.1), hematocrit reached a normal value (from 45.4 to 42.5, ref value 34.5-42.5); and the amount of hemoglobin reached normal (see Table 2).

TABLE 2 Changes in blood and infectious status in “A.T.” Reference Before After 1 month Indices value treatment of treatment HSV IgG 1 6.74 9.7 CMV IgG 6 67.9 21 EBV IgG 0.8 11.47 15.93 Mycoplasma IgG 1 1.08 0 Helicobacter Pylori negative positive negative IgG Amount of  26-31 pg 25.4 pg 27 pg hemoglobin in erythrocytes Hematocrit 34.5-42.5% 45.4% 42.5% Erythrocytes 3.6-5.1    5.7 5.27 10{circumflex over ( )}12/L Distribution of 11.5-14.5% 17.4% 16.6% erythrocytes by volume

Example 3—4-Year-Old Male “A. R.”

Prior to treatment, the child's parents reported that the child displayed the followed signs and symptoms of ASD: absence of speech (only one word in the vocabulary); stereotypical movements; excessive focus on numbers and letters; minor difficulties in communication with other children; aggressive behavior when he was not allowed to do what he wanted; hyperactivity; and frequent colds.

The test for the presence of infections revealed rubella IgG. The blood test showed the increased level of erythrocytes and hematocrit.

After 2 months of the subject antiviral and supplement treatment, the parents reported the following changes: the child started speaking with short sentences; he became more communicative, for example, saying when he wanted something; he started singing songs; there were 30 new words in his vocabulary; he started looking into people's eyes when speaking to them and tries to hold their hands; he became calmer; he cried less than previously; he started understanding complex instructions, including those having several consecutive actions; and during the whole period of treatment he never contracted a cold.

Blood tests revealed the following physiological changes: the level of erythrocytes decreased and approached to the normal value (from 4.9 to 4.6, ref value 3.5-4.5), and hematocrit index reached a normal value (from 40.8 to 39.3%, ref value 31-39.5%). At the same time, the level of lymphocytes decreased from 21% to 40.9% (ref value 25-60%), the level of neutrophils increased from 48.2% to 71.3% (ref value 25-60%), and distribution of erythrocytes by volume increased from 13.9% to 14.6% (ref value 11.5-14.5%) (see Table 3).

TABLE 3 Changes in blood and infectious status in “A.R.” Reference Before After 1 month Indices value treatment of treatment Rubella IgG 10 >500 >500 Erythrocytes 3.5-4.5    4.9 4.6 10{circumflex over ( )}12/L Hematocrit   31-39.5% 40.8% 39.3% Lymphocytes 25-60% 40.9% 21%   Neutrophils 25-60% 48.2% 71.3% Distribution of 11.5-14.5% 13.9% 14.6% erythrocytes by volume

Example 4—5-Year-Old Male “I. Z.”

I. Z. 5 year old boy had dramatically decreased speaking ability, severe difficulties with social communication and obsessive and fixated behavior diagnosed with “psycho-speech development delay” at age of 2.8. parents complaints were “lack of vocabulary, unwillingness to speak, difficulties in understanding addressed speech, lack of interest in peers, fixations, obsessiveness, anxiety and selectivity of food”

According to parents, pregnancy was complicated: prolonged pregnancy, parturition through cesarean section, the child was born with hypoxia. At the first months of life child was unusually quiet and did not need attention.

Prior to the current treatment, the child attended psychologist and defectologist, which resulted in some improvements in communication and behavior, speech therapist, ABA therapy and reflexotherapy.

Blood work. Lymphocytosis, increased hemoglobin, increased mean corpuscular volume (MCV) and mean corpuscular hemoglobin (MCH), neutropenia, detected IgG to CMV, EBV, HSV and rubella virus over reference ranges, decreased T-helpers count, increased B-lymphocytes count and T-lymphocytes count.

In 45 days the treatment was initiated: the level of hemoglobin, MCV, MCH did not change did not change, the level of lymphocytes decreased, the level of neutrophils increased, all immune cells parameters became within reference ranges, HSV status became negative, IgG to CMV, EBV, rubella virus reduced.

Moreover, more constructive speech appeared in the child's speech, attempts to speak more, better understanding and memorization. He became more initiative in classes, and less aggressive. He started expressing pity, became more attached to family members, and a sense of timing appeared. He also started trying new types of food. During treatment, the appetite decreased, and at the break appeared again.

Example 5—4-Year-Old Male “Y. S.”

Y. S. 4 year old boy with significantly reduced speaking ability, moderate problems with social communication, signs of rituality and repetitive behavior, diagnosed with “speech development delay with autistic patterns” at age of 3. Parents' complaints were “few words in the speech, impaired eye contact, lack of interest to peers, illogical statements in conversation, ritual behavior, repetitive movements and frequent constipations.”

According to the parents, pregnancy was complicated—risks of miscarriage several times during pregnancy. The child was unusually quiet, rarely cried, had operation for hydrocele at age of 7 months.

Prior to the subject treatment the child received the following therapies: Tomatis therapy, ABA therapy, speech therapy, body-oriented and exercise therapy, homeopathic therapy and lactose-free and gluten-free diet. As a result, better understanding, improved coordination, eye contact, more independence.

Blood work: Monocytosis, decreased mean platelet volume (MPV), increased erythrocytes sedimentation rate (ESD), detected IgG to rubella virus and HSV over reference ranges, increased T-lymphocytes and T-suppressors counts.

In 45 days the treatment was initiated: MPV did not change, monocytes count decreased, became close to reference ranges, ESD became within a reference range, IgG to rubella reduced, IgG to HSV increased, all immune cells parameters became within reference ranges.

Additionally the child began to speak more clearly, began to fool around, began to do the rogueries (looks into eyes and realizes that he made a mistake), tries to play with the computer, began to joke, became more self-dependent, and more open. He participated in a dialogue for the first time. His physical skills improved, increased sociability in relation to other children, an interest in spending time with children appeared. The stool became more frequent.

Example 6—8-Year-Old Male “T. B.”

T. B. 8 year old boy with significantly reduced speaking ability, severe problems with social communication, repetitive and restricted behavior of the severe level, and fixation, was diagnosed with “atypical autism” at age of 4. The parents' complaints were: “knows just few words, communicates through PECS cards only, does not communicate with others, confuses emotions, repetitive jumping and knocking, vocalizations, fixated interest to some objects, hypersensitivity, anxiety, hyperactivity and frequent respiratory infections”.

The parents did not answer the questions regarding pregnancy, parturition and first months of the child's life.

Prior to the treatment the child was treated by Valtrex and Viferon, as a result he is getting sick more rarely, learned to swim and to communicate through PECS cards. Later he was given 5-metylhydrofolate and Metylcobalamin B-12, which resulted in more self-dependence. Supplements: NutraMedix Burbur-Pinella, Detox Brain-Nerve Cleanse. The understanding of speech improved.

Blood work: Decreased MPV and MCV, monocytosis, erythrocytosis, detected IgG to CMV and rubella virus, reduced ratio T-helper/T-suppressor.

The treatment was initiated in 80 days: MPV decreased, erythrocytes and MCV—within reference range, monocytes count did not change, IgG to CMV and rubella virus slightly increased. However, some blood cells changed beyond the normal values: neutrophils decreased while eosinophils and lymphocytes increased. The immune parameters were not tested.

The following changes were noticed by parents: He started to understand requests and to communicate with other children, he says “bye” to children when they finish playing and became more tender and emotional to parents. the sleep significantly improved. Also stool improved, constipation stopped. His resistance to respiratory infections also improved.

Example 7—2.5-Year-Old Male “A. A.”

A. A. 2.5 year old boy had significantly reduced speaking ability, noticeable difficulties with social communication, mild repetitive behavior, diagnosed with “delay in psycho-speech development” and “attention deficit and hyperactivity disorder” at age 1 year 4 months. Parents complaints were “few words in vocabulary, inappropriate words in speech, impaired eye contact, preference to stay alone, ignoring other people, periodical repetitive movements”.

Pregnancy and birth were not complicated, according to parents. At 3 month the child had respiratory infection. At the first year of life the child was very quiet, rarely cried. At 10 months the first symptoms were noticed—he did not react to the name and became very hyperactive.

Prior to our therapy the following types of treatment were applied: Cogitum, Cortexin, Multivitamins, herbal extracts (echinacea, blueberry), probiotic Lysate and Omega 3; speech therapy, psychological therapy, defectologist and play therapy; bioacoustic correction. The parents did not indicate any changes after these therapies.

Blood work: All white and red blood cells parameters were within reference ranges, detected IgG to rubella over reference range, decreased T-lymphocytes, T-helpers counts and reduced ratio T-helper/T-suppressor, increased B-lymphocytes and T-suppressors counts.

The treatment was initiated in 45 days: All immune cells apart from T-suppressors became of a normal value, IgG to rubella increased.

Additionally, parents reported that the vocabulary increased, contact with other people improved, he started to react to other people's questions and understands other people better. Overall communication has improved repeatability of movements decreased, became more interested in drawing.

Example 8—5-Year-Old Female “A. Z.”

A. Z. 5 year old girl had moderate language impairment, severe social communication problems, and severe restricted and repetitive behavior, was diagnosed with “early organic damage to the central nervous system, psycho-speech development delay, organic-residual encephalopathy and ASD” at age of 2.7. Later the diagnosis of atypical autism with mental retardation was established at age of 4.6. The parents' complaints were: “limited vocabulary, rare speech, impaired eye contact, absence of any communication, difficulties in understanding addressed speech, no expression of emotions, echolalia, repetitive behavior, hypersensitivity, hyperactivity and selectivity of food.”

According to parents, pregnancy was complicated: at the first trimester there was a risk of miscarriage, bleeding, immature birth at 36^(th) week with hypoxia. After birth the child had jaundice and was diagnosed with megalothymus. At the first year of life-long sleep, was unusually calm, ignored people, was afraid of noises.

Prior to our treatment the child took: Cortexin, Encephabol, Pantocalcin, Noofen, Biomed. Glutamine, Gabu, enzyme for the welding of gluten, Omega 3, and some vitamins and minerals; ABA therapy; and gluten-free, casein-free, soy-free diet. The parents did not notice significant results after these therapies.

Blood work: Increased RDW and ESD, detected IgG to EBV (NA), CMV, and rubella virus over reference ranges, increased T-suppressor count and decreased NK count.

In 80 days the treatment was initiated: RDW did not change, ESD became of a reference range, neutrophils decreased below the reference value, IgG to EBV reduced, IgG to rubella virus and CMV did not change, T-suppressors increased—33.7%, NK cells became of a reference value—13.8%, and T-helper count decreased below the reference range.

Additionally, the parents reported that: the vocabulary increased, the child started to build phrases, repeats some words after mother. She became more responsive when people talk to her. Eye contact became longer, she started playing with siblings. Moreover, she became calmer, started studying at home, although before she could not due to hyperactivity. She learned to use toilet by herself and tried new types of food that she refused to try before.

Example 9—5-Year-Old Male “O. D.”

O. D. 5 year old boy had significantly reduced speaking ability, severe problems with social communication, restricted behavior and anxiety, diagnosed with ASD at age 2.5. Parents complaints were: “only few words in vocabulary, rare usage of speech, difficulties with understanding addressed speech and other people's behavior, impaired eye contact, focusing on some objects, anxiety about losing personal belongings and selectivity of food.”

According to parents, the pregnancy was complicated: at the third trimester of pregnancy mother had respiratory infection. 3 months after birth the child had respiratory infection. Before age of 1, he was unusually quiet, could sit and look at toys, or watch cartoons, rarely smiled or laughed.

Prior to the antiviral treatment the child received the following drugs and therapies: Ganglioside, Cortexin, Ceraxon, Cerebrolysin, Gliatilin, Pantogam, Noofen, Mexidol, Encephabol; biomethod (probiotics, supplements and gluten-free casein-free diet), acupuncture and micropolarization. After all these treatments the child became more hyperactive, but some new words and phrases appeared in the speech.

Blood work: Neutropenia and increased ESD, detected IgG to EBV (NA) and rubella virus over reference ranges, decreased T lymphocytes, T-helper counts, reduced T-helper/T-suppressor ratio, and increased T-suppressor and NK cells counts.

In 80 days the treatment was initiated: Neutrophils count did not change; ESD became of a reference value; lymphocytes, eosinophils, monocytes and basophils counts reduced below reference ranges; IgG to EBV (NA) did not change; IgG to rubella reduced; and T-suppressors, NK cells count, and ratio T-helpers/T-suppressors did not change, all other immune cells became of a reference ranges.

Additionally parents reported that: vocabulary increased, for the first time he said the full sentence, he started using words and phrases appropriately in the speech, communicative skills improved, became more tender, expresses love towards family members, started communicating with other children, parents as well as teachers noticed that he became calmer, hysterias occur more rarely, instead he argues with words to show his unwillingness to do something, but calms down very soon, vocalizations stopped, his eye contact improved, muscle strength increased, he can climb the stairs by himself, started trying new types of food, and appetite improved.

Example 10—5-Year-Old Male “M. K.”

M. K. 5 year old boy had mild language impairment, echolalia, severe problems with social communication and understanding, had signs of compulsive-obsessive behavior and mild restricted and repetitive behavior, was diagnosed with ASD at age 3. Parents' complaints were “scanty speech, echolalia, repetition of question before answering, ignoring other people, unrelated answers, impaired eye contact, obsessive phrases, sequencing, ritualism and hyperactivity.”

The parents did not answer the questions regarding pregnancy, parturition and first months of the child's life.

Prior to the subject therapy the following drugs and therapy were applied: Omega-3; Tomatis therapy, psychologist, speech therapist and defectologist, exercise therapy, hippotherapy; homeopathy, BAC, acupuncture. As the result concentration and understanding has improved, solved the problem of nocturnal enuresis, improved general physical skills, slightly improved speech.

Blood work: Erythrocytosis, thrombocytosis, neutrophilia, eosinophilia, lymphocytosis, increased hematocrit, and ESD, detected IgG to CMV, HSV, EBV (EBNA), rubella virus and IgM to Giardia were over reference ranges, reduced T-helpers/T-suppressors ratio.

In 45 days the treatment was initiated: thrombocytes, neutrophils, eosonophils and ESD became within reference ranges, hematocrit and lymphocytes count did not change, hemoglobin and RDW increased over reference ranges, IgG to CMV increased slightly, IgG to HSV did not change, IgG to EBV reduced significantly, IgM to Giardia—within reference range, IgG test to rubella virus was not completed. CD4/CD8 ratio reduced, B-lymphocytes and T-helper counts reduced below the reference range.

Additionally, parents reported that: vocabulary increased, he started to use speech more often, remembered the words that he had learned before the regression, builds phrases. He now expresses a willingness to interact with other children, starts to understand how to communicate with peers, socialization has improved. Nonverbal communication has also improved, in his responses understanding and adequacy appeared. Also, parents reported that his memory has improved—he remembers some situations, tells how his day was.

Example 11—5-Year-Old Male “A. B.”

A. B. 5 year old boy had significantly reduced speaking ability, severe social communication problems, mild repetitive and restricted behavior, was diagnosed with ASD at age of 3. Parents' complaints were “usage of only few learned words, inability to communicate with other children, impaired eye contact, problems with understanding, absence of dialogues, repetitive finger movements, hyperactivity, anxiety and frequent respiratory infections.”

According to parents, pregnancy and parturition were not complicated, but the child was born with hypoxia. From the first days after birth, the child was unusually calm, did not need attention, did not feel pain.

Prior to the subject treatment, the child received the following therapies: speech therapy, defectologist, psychologist; microcurrent reflexotherapy, osteopathy, massage, acupuncture. As the result, only the physical condition of the child has improved.

Blood work: Decreased MCH, increased RDW and trombocrit, detected IgG to EBV and rubella virus are over reference range, decreased T-lymphocytes, T-helper, T-suppressor, B-lymphocyte counts.

In 80 days the treatment was initiated: red blood cell count did not change, but also thrombocytosis appeared, IgG to rubella virus and EBV decreased, T-lymphocytes are within reference range, other immune cells count did not change.

Additionally, the parents reported that the child started actively trying to repeat some new words and to talk more, eye contact improved, motor skills improved. During the treatment, the child had respiratory infection, and the process of recovery was easier and quicker.

Example 12—3-Year-Old Male “K. S.”

K. S., a 3 year old boy with significantly reduced speaking ability, moderate restricted and repetitive behavior, severe difficulties with social communications, and anxiety, was diagnosed with speech development delay with autistic behavior in age of 2.6. Parents' complaints were “lack of speech, periodical repetitive behavior, biting his fingers, frequent hysterias, impaired eye contact, and inability to communicate.”

According to parents, the child was born with hypoxia, in the early childhood he was restless, often cried, did not look into eyes, and had sleep deprivation.

Prior to our treatment, the child received the following drugs and therapies: Valtrex, Gammalon; ABA therapy, Montessori method, massage, speech therapy; microcurrent reflexotherapy. According to parents, the most effective was Valtrex. After this he became more communicative, attempts to speak appeared, became calmer, eye contact has improved.

Blood work: Lymphocytosis, erythrocytosis, eosinophilia, basophilia, increased hematocrit, detected IgG to HSV, EBV (VCA), Mycoplasma spp. and H. Pylori were above reference ranges, NK cells and T-Iymphocytes counts as well as T-helper/T-suppressor ratio were decreased.

In 80 days the treatment was initiated: eosinophils and basophils counts decreased, erythrocytes count and hematocrit did not changes, at the same time the monocytes count increased above reference ranges, IgG to H. Pylori decreased to a reference range, IgG to mycoplasma, HSV and EBV did not change, immune cells count did not change.

Additionally, parents reported that the child started speaking, some new words appeared, he built 3 new sentences for the first time, started to understand addressed speech, eye contact has significantly improved, became more interested in peers and more communicative, defends himself if someone pushes him, became more self-dependent, anxiety disappeared, sensitivity became normal—stopped biting his fingers.

Example 13—3-Year-Old Female “A. R.”

A. R., a 3 year old girl had significantly reduced speaking ability, difficulties with understanding of addressed speech, mild restricted and repetitive behavior, anxiety and hyperactivity, was diagnosed with “speech development with autistic behavior” at age of 3. Parents' complaints were: “few words in the vocabulary, inability to speak clearly, misunderstanding of addressed speech and as a result impaired social communication skills, restricted behavior, difficulties in expressing emotions, anxiety, claustrophobia and hyperactivity.”

According to the parents, the pregnancy was complicated: respiratory infection in the second trimester, low hemoglobin during pregnancy. Parturition was with long anhydramnious period. The child was born with hypoxia. During the first months of life the child was restless, cried a lot, problems with sleep were present, and frequent respiratory infections.

Prior to our treatment, the child received the following types of treatment: Cortexin, Pancalcin, Efalex, Vitamins B; microcurrent reflexotherapy. None of these treatments gave positive results.

Blood work: Neutropenia, increased RDW, detected IgG to rubella virus, EBV and CMV are above reference ranges, B-lymphocyte, T-suppressor counts are increased, NK cells count is decreased.

In 30 days the treatment was initiated: neutrophils became of a reference range, RDW did not change, but erythrocytes count and hematocrit slightly increased above reference ranges, IgG to all detected viruses slightly increased. Immune cells analysis was not conducted.

Additionally, the parents reported the following changes: the understanding of speech improved, the child became more self-dependent, claustrophobia stopped.

Example 14—8-Year-Old Male “A. A.”

A. A., an 8 year old boy had mild language impairment, mild social communication problems and moderate restricted and repetitive behavior, sleep deprivation, anxiety and hyperactivity. He was diagnosed with ASD at age 3.5. Parents' complaints were “short phrases with wrong construction, repetitive behavior and restriction on some objects, misunderstanding of how to communicate with other people, inadequate reaction when interest towards him is demonstrated, signs of obsessive-compulsive syndrome, hyperactivity, anxiety, sleep deprivation and selectivity of food.”

Parents did not provide the information on pregnancy, parturition and first months of the child's life.

Prior to the subject treatment the child received the following therapies: ABA therapy, exercise therapy, massage, speech therapy, psychological therapy, manual therapy, and Tomatis. These therapies as a complex, slightly improved social communication skills, language skills and improved behavior.

Blood work. Leukopenia, eosinophilia, detected IgG to rubella virus, EBV and CMV were above reference ranges, reduced T-helper count and reduced T-helper/T-suppressor ratio.

In 45 days the treatment was initiated: leukopenia did not change, eosinophils count—within reference ranges, monocytes count increased above reference range, IgG to EBV reduced by 13 times, IgG to rubella did not change, IgG to CMV increased slightly. Immune analysis was not conducted.

Additionally, the parents reported the following changes: the speech became more complicated—new phrases, sentences, which became more grammatically correct, pronunciation became more clear, repetitive behavior notably decreased, eye contact improved—often looks and for long, became more sociable, plays more often with other children and started to initiate games by himself, sleep is better—falls asleep much faster (30 min instead of 2 h), started trying new types of food.

Example 15—7-Year-Old Male “D. M.”

D. M., a 7 year old boy had no speech, severe repetitive and restricted behavior, difficulties regarding communication due to absence of speech and misunderstanding of the addressed speech. He was diagnosed with ASD at age of 4. Parents' complaints were “absence of speech, constant stereotypical behavior, misunderstanding how to communicate with other people, problems with nonverbal communication, selectivity of food and hypersensitivity.”

According to parents, the pregnancy was complicated: respiratory infection in the second trimester, the child was born with asphyxia, the child was unusually quiet from the first days of life, fell asleep by himself, did not need attention, had frequent respiratory infections.

Prior to our treatment the child received the following drugs and therapies: Pantogam, Cortexin, Tenoten, Mexidol, Depakin, Gliatilin, Sturegon; massage, microcurrent reflexotherapy. After these treatments the parents did not notice significant results. After some of the drugs the child became more hyperactive.

Blood work: Erythrocytosis, neutropenia, basophilia, lymphocytosis, increased MCV, detected IgG to CMV, EBV, HSV and rubella virus were above reference ranges. All immune cells—within reference ranges.

In 120 days the treatment was initiated: erythrocytes count became within reference range, all other parameters did not change, IgG to rubella virus and CMV increased, IgG to EBV and HSV decreased, T-helper/T-suppressor ration decreased below reference range.

Additionally, the parents reported that during the treatment the child for the first time said phrase “I will,” he became attached to his favorite toy, he takes it everywhere—before he did not have such attachment.

Example 16—5-Year-Old Male “K. T.”

K. T., a 5 year old boy had moderate language impairment, moderate social communication problems and restricted and repetitive behavior, hypersensitivity and hyperactivity. The child was diagnosed with psycho-speech development delay at age of 2. Parents' complaints were “undeveloped speech, inability to build phrases, restriction on some objects, misunderstanding of how to communicate with others, hearing hypersensitivity, severe hyperactivity.”

According to the parents, the pregnancy was complicated: CMV infection during pregnancy, the child was born with asphyxia due to umbilical cord vein. After birth the child was unusually quiet, could lay by himself for a long time.

Prior to the subject treatment the child received the following therapies: gluten-free, casein-free diet, microcurrent reflexotherapy. After these, the parents did not notice any results.

Blood work: Increased hematocrit and MCHC, decreased PTW, neutropenia and basophilia, detected IgG to CMV, EBV and rubella virus above reference ranges, EBV, CMV and HSV were detected using PCR method, increased NK cells count, decreased B-lymphocytes count, reduced T-helpers/T-suppressors ratio.

In 80 days the treatment was initiated: PTW, neutrophils count, basophils count—within reference ranges, hematocrit, MCHC did not change, erythrocytosis, thrombocytosis, decreased MPV. IgG to EBV and CMV decreased, IgG to rubella increased. Immune cells—all within reference ranges, apart from reduced T-helpers/T-suppressors ratio.

Additionally, the parents reported: the speech became more clear, new complex sentences appeared, vocabulary increased, started asking questions, became more sociable, tries to initiate games, more attentive to other children, understanding of addressed speech improved, eye contact became more conscious, hearing sensitivity reduced, became calmer, new skills appeared: drawing, singing.

Example 17—3-Year-Old Male “K. D.”

K. D. 3 y.o. boy had no speech, severe difficulties with social communication, severe repetitive and restricted behavior. The child was diagnosed with child autism at age of 3. The parents' complaints were “absence of speech, frequent repetitive and restricted behavior, impaired eye contact, ignoring other people, lack of interest to other children, inability to express emotions”.

According to the parents, the pregnancy was complicated, there was a risk of miscarriage in the first semester of pregnancy, the child was born with hypoxia. During the first year of life the child was very quiet, rarely cried.

Prior to our treatment the child received microcurrent reflexotherapy method. After this the regression of autistic symptoms occurred.

Blood work. Erythrocytosis, neutropenia, lymphocytosis, decreased MCH, detected IgG to CMV was above reference range. All immune cells were within reference ranges.

In 45 days the treatment was initiated: erythrocytes, neutrophils, lymphocytes count—within reference ranges, decreased MCH, thrombocytosis, IgG to CMV decreased by 77 times. Immune cells analysis was not conducted.

Additionally, parents reported that vocabulary increased, started to understand addressed speech, became calmer, the sense of empathy appeared.

Example 18—3-Year-Old Male “E. A.”

E. A. 3 y.o. boy had no speech, severe problems with social communication and mild repetitive and restricted behavior. He was diagnosed with ASD at age of 2. Parents' complaints were “absence of speech, only separate sounds, misunderstanding of how to play and communicate with other children, reduced spectrum of emotions, stereotypical games, preference to be separate from peers, impaired eye contact, reduced sensitivity, GI and respiratory tracts frequent disorders”.

According to parents, the pregnancy was complicated: respiratory infection in the second trimester of pregnancy. After birth the child was unusually quiet, rarely pronounced any sounds, and even if cried did it very quietly.

Prior to our treatment the child received Cerebrolysin, Ceraxon, Pantocalcin, Pantogam, Tenoten, Encephabol, Noofen, Gliatylin; speech therapy, osteopathy; BAC, transcranial polarization. These treatments resulted in appearance of new sounds, improved eye contact, improved behavior and physical skills.

Blood work. Erythrocytosis, neutropenia, lymphocytosis, eosinophilia, increased MCH, MCV, and RDW. Detected IgG to rubella virus, CMV, EBV, HSV, Mycoplasma are above reference ranges. Decreased B-lymphocytes count.

In 45 days the treatment was initiated: blood cells count did not change, apart from eosinophils count, that became within reference range, IgG to HSV and mycoplasma—within reference ranges, IgG to EBV, CMV and rubella did not change significantly, all immune cells—within reference ranges.

Additionally, parents reported that the child became more communicative, started to use gestures for communication, constructs dialogues in that way, learned new sounds, pronounces them with intonation, tries to say some words, started playing with other children, imitates others, reacts to and understands addressed speech, improved eye contact, does not focus that much on objects, disappoints when parents go to work, became more self-dependent, helps mother, more attached to family members, memorization improved, sleeps better.

Example 19—2-Year-Old Male “I. C.”

I. C. 2 y.o. boy had no speech, moderate problems with social communication, mild repetitive and restricted behavior, severe hyperactivity, was diagnosed with psycho-speech development delay at age of 2. Parents' complaints were “no speech, no understanding of addressed speech, misunderstanding of how to communicate with others, ignoring others, pronounced hyperactivity, gastrointestinal tract disorders, allergy”.

Parents did not provide the information of pregnancy, parturition and first year of the child's life.

Prior to our treatment, the child received the following therapies: massage, gluten-free, lactose-free diet, speech therapy, correctional therapy. After these therapies parents did not notice any significance differences.

Blood work. Neutropenia, lymphocytosis. EBV was found in saliva using PCR method. Decreased t-helper, T-suppressor counts and reduced T-helpers/T-suppressors ratio.

In 45 days the treatment was initiated: neutrophils and lymphocytes counts—within reference ranges, monocytosis. T-helpers count and T-helpers/T-suppressors ratio—within reference ranges. T-suppressors and B-lymphocytes counts decreased.

Additionally, parents reported that the child started to repeat more words after parents, behavior improved, understanding of addressed speech improved, if people around start laughing, he laughs too.

Example 20—11-Year-Old Male “S. Z.”

S. Z. 11 y.o. boy had moderate language impairment, severe restricted and repetitive behavior, moderate social communication problems, hypersensitivity, anxiety and hyperactivity. Was diagnosed with regressive autism at age of 3. Parents' complaints were “reduced speaking ability, short sentences, speech defects, unwillingness to communicate, frequent repetitive behavior, fixations, anxiety when stays alone at home, lack of interest to peers, unrelated answers, hearing hypersensitivity, and reduced sensitivity to pain, hyperactivity”.

According to parents, the parturition was immature, the child was born with weight deficit. At first months of life there were delays in physical skills, was unusually quiet.

Prior to our treatment the child received the following treatment: Nistatin, Memantine, dolphin therapy, Tomatis, speech therapy, occupational therapy, game therapy, gluten-free, lactose-free, soy-free diet. According to parents, none of these methods showed significant results.

Blood work. Erythrocytosis, basophilia, increased hemoglobin, hematocrit, and MCV, detected IgG to EBV, CMV, rubella virus and H. pylori are above reference ranges, reduced T-helpers/T-suppressors ratio.

In 45 days the treatment was initiated: blood parameters did not change, apart from basophils which became of reference range and appeared neutropenia and eosinophilia. IgG to H. pylori—within reference range, IgG to EBV, rubella virus and CMV decreased. Reduced T-helpers/T-suppressors ratio.

Additionally, the parents reported that the vocabulary increased, the speech became more clear, the child started speaking to himself, eye contact improved, stopped biting his nails.

Example 21—Summary of Results

TABLE 4 The summary of the positive results obtained after treatment in each category. Problem Result of the treatment Social Understanding of addressed speech appeared, communication a child became more communicative, improved problems eye contact and nonverbal communication, empathy appeared, attachment and tenderness to family members, started playing with peers, began to joke, reacting to other people, improved socialization, usage of gestures for communication Language Increased vocabulary, ability to build sentences, impairment clearer speech, more conscious and constructive speech, grammatically correct speech, participation in dialogues, verbal expression, repetition of words after parents, more complex sentences Repetitive and Reduced repetitive movements, echolalia, less restricted excessive focusing behavior Neurological A child became calmer, less anxious, less and hyperactive, hyper- or hyposensitivity reduced, psychological more initiation, less aggressiveness, improved problems sleep, studying process improved, GI and Less frequent respiratory and GI infections, more respiratory frequent stool, loss of excessive tracts disorders weight, trying new types of food, less constipation, improved appetite, Other skills Improved writing skills, drawing, singing, physical skills, motor function, logical thinking, memorization, more self-dependence,

TABLE 5 Description of the positive results in social communication problems after treatment. # of children # of with Description children changes of social having in social # of children— communication the commu- description of problems problems nication changes Inability to initiate 20 19 12—improved and to participate understanding of in communication, addressed speech Ignoring other 12—a child became people, more communicative Lack of interest 9—improved eye to peers, contact Misunderstanding 3—improved nonverbal of nonverbal communication communication, 3—empathy appeared Impaired eye contact, 4—attachment and Inability to express tenderness to emotions, family members Preference to stay 7—started playing with separate from others, peers Misunderstanding of 2—began to joke and the addressed speech to understand jokes Unrelated and 3—started reacting to illogical statements other people 1—usage of gestures for communication

TABLE 6 Description of the positive results in descriptive and repetitive behavior after treatment. # of children # of with Description of children changes in restricted and having restricted and # of children— repetitive the repetitive description of behavior problems behavior changes Repetitive motor 20 8 3—reduced repetitive movements, movements Stereotypical 1—reduced echolalia movements, 4—less excessive Echolalia, focusing Excessive focusing and fixation on some objects, Obsessive behavior, Rituality, Vocalization, Sequencing

TABLE 7 Description of the positive results in language impairment after treatment. # of children # of with Description of children changes language having in # of children— impairments the language description according to DSM-5 problems skills of changes Nonverbality, 20 17 12—increased Significantly vocabulary reduced vocabulary, 7—ability to build Inability to build sentences sentences, 4—clearer speech Scanty speech, 2—more conscious and Problems with constructive speech pronunciation, 4—participation in Grammatically dialogues incorrect speech, 5—verbal expression Rare usage of speech, 3—repetition of words No participation after parents in dialogues, Speech defects

TABLE 8 Description of the positive results in neurological and psychological problems after treatment. # of children Description of # of with changes in neurological children neurological and having and # of children— psychological the psychological description of problems problems problems changes Sleep disorders, 14 12 6—reduced Anxiety, hyperactivity Hyperactivity, 3—reduced anxiety Passiveness 2—reduced hyper- Hypersensitivity, or hyposensitivity Hyposensitivity, 2—improved sleep Aggressiveness, 2—improved Self- studying process aggressiveness,

TABLE 9 Description of the positive results in GI and respiratory after treatment. # of children with changes Description # of in GI and of GI and children respiratory # of children— respiratory having the tracts description of tracts disorders problems disorders changes Selectivity 12 9 3—less frequent of food, respiratory Constipations, and GI infections Frequent 1—loss of excessive respiratory weight infections, 4—trying new types GI disorders, of food Allergy 2—less frequent constipations

TABLE 10 Description of the positive results in other categories after treatment. # of children with changes in other skills Description of changes 12 1—improved writing skills 3—increased imagination 3—improved physical skills and motor function 1—improved logical thinking 3—improved memorization 6—more self-dependence 

1. A supplement composition for improving the quality of life in a subject with autism spectrum disorder (ASD), the composition comprising: L-lysine, Elderberry extract, olive leaf extract, Astragalus root extract, and Bacillus coagulans GBI-30 probiotic (BC30).
 2. The composition according to claim 1, the composition consisting essentially of: L-lysine, Elderberry extract, olive leaf extract, Astragalus root extract, and BC30.
 3. (canceled)
 4. The composition of claim 1, wherein the composition is formulated as an orally-ingestible product.
 5. (canceled)
 6. The composition of claim 4, wherein the composition is a chocolate bar, a gummy candy or a jelly candy.
 7. The composition of claim 1, wherein each of L-lysine, Elderberry extract, olive leaf extract, and Astragalus root extract is present in an amount from 125 mg to 750 mg.
 8. (canceled)
 9. The composition of claim 1, wherein each of L-lysine, Elderberry extract, olive leaf extract, and Astragalus root extract is present in an amount from 125 mg to 250 mg.
 10. The composition of claim 1, wherein the amount of BC30 is 1×10⁸ to 1×10¹² CFU.
 11. (canceled)
 12. The composition of claim 1, wherein the amount of BC30 is 2 billion CFU.
 13. A method for improving the quality of life in a subject diagnosed with ASD, which comprises administering a therapeutically effective dose of an antiviral compound to the subject and administering the supplement composition of claim 1 to the subject, wherein the method leads to improvement in ASD symptoms, improvement in the subject's behavioral performance, improvement in the signs and symptoms of infection in the subject, and/or improvement in the subject's overall immune health.
 14. The method of claim 12, wherein the antiviral compound is selected from the group consisting of: valacyclovir, acyclovir, ganciclovir and famciclovir.
 15. The method of claim 13, wherein the antiviral compound is valacyclovir.
 16. The method of claim 12, further comprising, prior to administration of the antiviral compound, diagnosing the subject with ASD.
 17. The method of claim 12, further comprising, prior to administration of the antiviral compound, testing the subject for a viral infection and/or testing the state of the subject's immune health.
 18. The method of claim 17, wherein the subject tests positive for one or more viral infections and/or immunocompromising conditions.
 19. The method of claim 12, wherein the subject is sixteen years of age or younger. 20-21. (canceled)
 22. The method of claim 20, wherein the dose of antiviral compound is 125 mg, and wherein the supplement composition comprises 2 billion CFU of BC30 and 125 mg each of L-lysine, Elderberry extract, olive leaf extract and Astragalus root extract. 23-24. (canceled)
 25. The method of claim 12, wherein the supplement composition is administered to the subject orally.
 26. A method for improving the quality of life in a subject diagnosed with ASD, which comprises administering to the subject a therapeutically effective amount of the composition of claim
 1. 